Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.
Biological: MultiStem
intravenous infusion
Biological: Placebo
intravenous infusion
Inclusion Criteria:
Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria,
requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or
systemic infection
Exclusion Criteria:
Moribund subject who, in the opinion of the Investigator, is not expected to survive at
least 48 hours and End-stage severe chronic lung disease
Athersys Investigational Site 107
Chicago, Illinois, United States
Athersys Investigational Site 103
Akron, Ohio, United States
Athersys Investigational Site 101
Cleveland, Ohio, United States
Athersys Investigational Site 102
Cleveland, Ohio, United States
Athersys Clinical Trials Group
2164263597
macovia@athersys.com
Eric Jenkins, MD, Study Director
Athersys, Inc